EU Pharmacovigilance Risk Assessment Committee clears Diane 35 (Bayer) for Acne

During its meeting of 13 to 16 May 2013, the EMA Pharmacovigilance Risk Assessment Committee (PRAC) concluded that the benefits of Diane 35 (Bayer HealthCare) and other medicines containing cyproterone acetate 2 mg and ethinylestradiol 35 micrograms continue to outweigh their risks for the treatment of moderate to severe Acne related to androgen sensitivity and/or hirsutism (excessive unwanted growth of hair in women) in women of reproductive age. In addition, the PRAC recommended that these medicines, when used for the treatment of Acne, should only be used when alternative treatments (topical treatments and antibiotics) have failed. The PRAC also recommended changes to the product information and other measures to reduce the risk of thromboembolism (the formation of blood clots in the blood vessels).